Your session is about to expire
← Back to Search
Palbociclib + Chemotherapy for Childhood Leukemia and Lymphoma
Phase 1
Waitlist Available
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients <= 16 years of age
Patients with first or greater relapsed T-lineage ALL or LL and second or greater relapsed B-lineage ALL or LL are eligible.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial is testing a new cancer drug in children with leukemia or lymphoma who have relapsed after previous treatment.
Who is the study for?
This trial is for children with relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL). They should have a certain level of bone marrow blasts, measurable disease, and be in good enough health to participate. Patients must not have been treated with palbociclib before and should meet specific heart, kidney, and liver function requirements.Check my eligibility
What is being tested?
The study tests the drug palbociclib combined with standard chemotherapy in pediatric patients who've had ALL or LL return after treatment. Palbociclib will be given at a starting dose of 50 mg/m^2/day for 21 days alongside re-induction chemotherapy.See study design
What are the potential side effects?
Possible side effects include low blood cell counts leading to increased infection risk, bleeding or bruising; fatigue; nausea; hair loss from chemotherapy; and potential heart or liver issues due to medication toxicity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mostly able to care for myself, regardless of my age.
Select...
My leukemia has relapsed at least once for T-lineage and twice for B-lineage.
Select...
I have never taken palbociclib or similar medications.
Select...
My heart is strong, with a good pumping efficiency.
Select...
My leukemia involves more than 5% of immature blood cells in my bone marrow.
Select...
My condition did not improve after at least 2 initial treatments or it came back and did not improve with another treatment.
Select...
My leukemia has relapsed with more than 5% bone marrow blasts.
Select...
My kidney function is good based on tests.
Select...
My liver is functioning well according to my recent tests.
Select...
My leukemia or lymphoma has come back or didn't respond to treatment.
Select...
My leukemia or lymphoma has come back or didn't respond to treatment.
Select...
My lymphoma can be measured or observed.
Select...
I am mostly able to care for myself and carry out daily activities.
Select...
My leukemia has relapsed at least once for T-lineage and twice for B-lineage.
Select...
My disease didn't respond to at least 2 initial treatments or didn't respond to treatment after the first relapse.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area under the drug concentration curve of Palbociclib
Clearance of Palbociclib
Frequency of adverse events of Palbociclib
+4 moreSecondary outcome measures
Absolute peripheral blast count of palbociclib
Antitumor effect of Palbociclib
CD1a biological activity of palbociclib
+12 moreSide effects data
From 2023 Phase 2 trial • 55 Patients • NCT0300797996%
White blood cell count decreased
87%
Neutrophil count decreased
80%
Anemia
74%
Lymphocyte count decreased
67%
Hypertension
61%
Fatigue
56%
Diarrhea
54%
Nausea
43%
Platelet count decreased
41%
Alopecia
39%
Headache
39%
Hot flashes
37%
Dizziness
37%
Insomnia
37%
Dyspepsia
35%
Anorexia
35%
Hyponatremia
35%
Cough
35%
Arthralgia
35%
Aspartate aminotransferase increased
33%
Edema limbs
33%
Alanine aminotransferase increased
33%
Creatinine increased
31%
Hyperkalemia
31%
Hypercalcemia
31%
Mucositis oral
31%
Vomiting
31%
Hypocalcemia
30%
Dyspnea
30%
Alkaline phosphatase increased
30%
Back pain
28%
Constipation
26%
Pain
26%
Hypokalemia
24%
Chills
20%
Hyperglycemia
20%
Dysgeusia
20%
Depression
20%
Myalgia
20%
Fall
19%
Pain in extremity
19%
Rash maculopapular
17%
Upper respiratory infection
17%
Peripheral sensory neuropathy
17%
Sinusitis
17%
Fever
17%
Anxiety
17%
Sore throat
15%
Hypoalbuminemia
13%
Hyperhidrosis
13%
Urinary tract infection
13%
Bone pain
13%
Nasal congestion
13%
Dry skin
11%
Hypernatremia
11%
Allergic rhinitis
11%
Weight loss
9%
Epistaxis
9%
Hypophosphatemia
9%
COVID-19
9%
Dysphagia
7%
Blurred vision
7%
Tooth infection
7%
Non-cardiac chest pain
7%
Skin infection
7%
Vertigo
7%
Breast pain
7%
Bronchitis
7%
Postnasal drip
7%
Common cold
7%
Neck pain
7%
Lymphedema
6%
Death
6%
Cellulitis
6%
Cataract
6%
Itchy skin
6%
Dehydration
6%
Knee pain
6%
Psoriasis
6%
Body aches
6%
Buttock pain
6%
Lung infection
6%
Allergic reaction
6%
Hypoglycemia
6%
Urinary frequency
6%
Osteopenia
6%
Rash acneiform
6%
Gout
6%
Bug bite
6%
Arthritis
6%
Thromboembolic event
4%
Vaginal dryness
4%
Watering eyes
4%
Burn
4%
Flu-like symptoms
4%
Edema trunk
4%
Back spasms
4%
Dry eye
4%
Sinus pain
4%
Head injury
4%
Memory impairment
4%
Skin bump
4%
Right arm numbness
4%
Nodule
4%
Hip pain
4%
Peripheral motor neuropathy
4%
Hypothyroidism
4%
Broken tooth
4%
Abdominal pain
4%
Dry lips
4%
Toothache
4%
Tick bite
4%
Extremity infection
4%
Hypomagnesemia
4%
Generalized muscle weakness
4%
Pleural effusion
4%
Sleep apnea
4%
Right thumb bump
4%
Osteonecrosis of jaw
4%
Chest pain - cardiac
4%
Acute kidney injury
4%
Muscle cramp
4%
Muscle spasm
4%
Gastroesophageal reflux disease
4%
Bruising
4%
Burn - left hand
4%
Brittle nail
2%
Bilateral nares sores
2%
Puncture wound
2%
Cold sweats
2%
Localized edema
2%
Wrist fracture
2%
Activated partial thromboplastin time prolonged
2%
Lung cancer
2%
Vaginal discharge
2%
Laryngeal inflammation
2%
Erythema multiforme
2%
Erythema right breast
2%
Paronychia
2%
Intrascapular pain
2%
Vaginal infection
2%
Hoarseness
2%
COPD
2%
Sinus congestion
2%
Sinus tachycardia
2%
Diverticulitis
2%
Sepsis
2%
Yeast infection
2%
Hyperuricemia
2%
Facial nerve disorder
2%
Paresthesia
2%
Agitation
2%
Urinary retention
2%
Oral fissure
2%
Eye lid pain
2%
Pharyngitis
2%
Blood bilirubin increased
2%
Flank pain
2%
Cognitive disturbance
2%
Radiation recall reaction (dermatologic)
2%
Photophobia
2%
Generalized weakness
2%
Rhinovirus
2%
Wound infection
2%
Hemorrhoids
2%
Fracture
2%
Vaginal itching
2%
Fever blister
2%
Wrist pain
2%
Leg pain
2%
Bladder infection
2%
Fungal toe infection
2%
Respiratory syncytial virus (RSV)
2%
Hypermagnesemia
2%
Urine discoloration
2%
Nail loss
2%
Shoulder nodule
2%
Peeling lips
2%
Vaginal itch
2%
Head injury - upper left occipital swelling
2%
Acoustic neuroma
2%
Eye lid pain/soreness
2%
Open cutaneous area left breast
2%
Peeling skin palms of hands
2%
Mole pain
2%
Itchy scalp
2%
Spinal fracture
2%
Asthma
2%
Hand cramps
2%
Left hand puncture wound
2%
C. difficile
2%
Gait disturbance
2%
Myocardial infarction
2%
Red eye
2%
Groin pain
2%
Superficial thrombophlebitis
2%
Paronychia - infection right middle
2%
Snake bite
2%
Hemoglobin increased
2%
Muscle weakness lower limb
2%
Right arm pain
2%
Mitral valve disease
2%
Tinnitus
2%
Vestibular schwannoma
2%
Dry mouth
2%
Oral dysesthesia
2%
Oral pain
2%
Stomach pain
2%
Ulcerative colitis
2%
Acute bronchitis
2%
Otitis media
2%
INR increased
2%
Lymphocyte count increased
2%
Bilateral leg pain
2%
Chest wall pain
2%
Left sided flank pain
2%
Sternum pain
2%
ADHD
2%
Confusion
2%
Sacroliac joint pain
2%
Shoulder pain
2%
Hallucinations
2%
Mood swings
2%
Nasal dryness
2%
Productive cough
2%
Voice alteration
2%
Hypotension
2%
Cold sensitivity
2%
Sciatic pain
2%
Nasal drainage
2%
Heart failure
2%
Skin bumps
2%
Skin hypopigmentation
2%
Leg stiffness
2%
Asystole
2%
Failure to thrive
2%
Intracranial hemorrhage
2%
Gastric ulcer
2%
Gingival pain
2%
Hematochezia
2%
Hemorrhoidal hemorrhage
2%
Dilation of appendix with periappendiceal fat stranding seen on CT
2%
Edema face
2%
Yeast infection under right breast
2%
Weight gain
2%
Spasticity
2%
Syncope
2%
Blister
2%
Sores bilateral nares
2%
Stomach rash
2%
Tender nail bed
100%
80%
60%
40%
20%
0%
Study treatment Arm
Palbociclib + Letrozole or + Fulvestrant
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (Palbociclib)Experimental Treatment9 Interventions
Patients receive Palbociclib 50 mg/m^2 (starting dose with maximum dose of 100 mg) PO (or via NG-tube) once daily on Days 1-21; Intrathecal cytarabine (IT ARAC) age-based dosing on Day 1, Doxorubicin 60 mg/m^2 IV push or infusion over 1-15 min on Day 4; Prednisone or prednisolone 40 mg/m^2 PO divided BID or TID on days 4-31; Vincristine 1.5 mg/m^2 (maximum dose 2 mg) IV push or mini-bag per institutional policy on days 4, 11, 18, and 25; and Pegaspargase 2500 IU/m^2 IV over 1-2 hours on Days 5, and 18. If CNS3 leukemia is present, patients receive Intrathecal Triple Therapy (ITT) age-based dosing on days 4, 11, 18, and 25. Patients known to be CNS3 at study entry may receive ITT on Day 1 rather than IT ARAC. If CNS1 and 2 leukemia present, patient receive Methotrexate (IT MTX) age-based dosing on Days 18 and 32. Treatment will be given for one cycle, 32 days, in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydrocortisone
2005
Completed Phase 4
~1260
Vincristine
2003
Completed Phase 4
~2910
Palbociclib
2017
Completed Phase 3
~3760
Doxorubicin
2012
Completed Phase 3
~7940
Prednisolone
2005
Completed Phase 4
~2720
Cytarabine
2016
Completed Phase 3
~3310
Methotrexate
2013
Completed Phase 4
~3800
Prednisone
2014
Completed Phase 4
~2370
Pegaspargase
2005
Completed Phase 3
~9010
Find a Location
Who is running the clinical trial?
Children's Oncology GroupLead Sponsor
453 Previous Clinical Trials
237,685 Total Patients Enrolled
Elizabeth Raetz, MDStudy ChairChildren's Oncology Group
2 Previous Clinical Trials
140 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am mostly able to care for myself, regardless of my age.You are currently taking part in another study that involves testing an experimental drug.I am not taking medication that strongly affects certain liver enzymes.I do not have any infections that are currently uncontrolled.My leukemia has relapsed at least once for T-lineage and twice for B-lineage.I have never taken palbociclib or similar medications.My heart is strong, with a good pumping efficiency.I am not on any cancer treatments, except possibly hydroxyurea which I can stop 24 hours before starting the trial.I am taking medication to prevent graft-versus-host disease after a bone marrow transplant.You are pregnant or currently breastfeeding.I am on standard chemotherapy and can join the trial without waiting.I have recovered from side effects of previous cancer treatments.I have not taken any cancer drugs known to lower my blood cell counts recently.I use a wheelchair but can sit up and move around in it.My leukemia involves more than 5% of immature blood cells in my bone marrow.I can swallow pills or liquids, or can take medication through an NG tube.I have recovered from previous cancer treatments and meet the required waiting period.My condition did not improve after at least 2 initial treatments or it came back and did not improve with another treatment.My leukemia has relapsed with more than 5% bone marrow blasts.My kidney function is good based on tests.My lymphoma can be measured or observed through tests.My liver is functioning well according to my recent tests.My leukemia or lymphoma has come back or didn't respond to treatment.My leukemia or lymphoma has come back or didn't respond to treatment.My lymphoma can be measured or observed.I am mostly able to care for myself and carry out daily activities.My leukemia has relapsed at least once for T-lineage and twice for B-lineage.My disease didn't respond to at least 2 initial treatments or didn't respond to treatment after the first relapse.I have a genetic condition like Down syndrome or Fanconi anemia.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (Palbociclib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please elucidate on any other research pertaining to Palbociclib?
"At the moment, 1129 clinical trials are underway that involve Palbociclib. Of those active studies, 302 have reached Phase 3 of testing. Though Changsha in Hunan Province is home to most research on this medication, 50836 other sites across the globe are engaging with these experiments as well."
Answered by AI
Are there any open slots available for participants in this research project?
"At this time, no patients are being accepted for the described study which was published on April 11th 2019 and edited most recently on February 25th 2022. However, 2901 studies recruiting people with T-Cell Leukemia and 1129 trials looking at Palbociclib as a treatment option remain open for enrollment."
Answered by AI
What is the upper capacity for enrollees in this clinical experiment?
"This medical trial is currently not recruiting participants. It was first introduced on April 11th, 2019 and the most recent update occurred February 25th, 2022. There are presently 2901 studies actively searching for patients with T-cell leukemia and 1129 trials hunting down Palbociclib users."
Answered by AI
To what condition is Palbociclib primarily prescribed?
"Palbociclib is a viable therapeutic approach to combat ailments such as ulcerative colitis, varicella-zoster virus acute retinal necrosis, and multiple myeloma."
Answered by AI
What is the full scope of locations where this research is being conducted?
"This study is currently running in 19 different hospitals, including Children's Hospital of Orange County and Primary Children's Hospital. One can also find sites at Cincinnati Children's Hospital Medical Center, as well as 16 other locations."
Answered by AI
What are the primary goals this research is aiming to achieve?
"This upcoming medical trial intends to measure the half-life of Palbociclib over a 4 year period. Auxiliary objectives include quantifying median values for absolute peripheral blast count, phospho-RB1 expression, and RB1 expression in relation to dose levels of the study drug."
Answered by AI
What are the criteria for inclusion in this research trial?
"This clinical trial has need of 15 individuals with T-cell leukemia between the ages of 12 Months and 31. Participants must meet certain criteria, including having ≥ 5% (M2 or M3) bone marrow blasts with or without an extramedullary site of relapse; being able to walk in a wheelchair; receiving cytotoxic chemotherapy or other myelosuppressive anti-cancer agents; suffering from recurrent/refractory B/T-lineage lymphoblastic leukemia/lymphoma, measurable/evaluable disease for LL patients, first+ relapsed T-ALL/LL & second+ relapsed B-"
Answered by AI
Are elderly individuals eligible for enrollment in this research endeavor?
"As per the requirements for eligibility, minors over 12 months old up to 31 years of age can partake in this clinical trial."
Answered by AI
How does Palbociclib impact safety for those who ingest it?
"Palbociclib received a score of 1, as this is an early stage trial and there are not many data points indicating its safety or effectiveness."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger